Generic Migranal (Dihydroergotamine Mesylate)

MIGRANAL

Migranal is a nasal spray treatment for migraines, proposed as an alternative to oral treatment for people whose symptoms aren't relieved (or aren't relieved quickly enough) by oral treatments, or for people who cannot take oral treatments due to migraine-related nausea or vomiting. While Migranal's nasal-spray form is new, the active ingredient in the medicine has been used to treat migraines for decades.

Proper Storage

Store at room temperature, away from heat, sunlight and moisture. Keep out of the reach of children.

Proper Usage

Read product leaflet carefully for information on how to place the medicine in the nasal sprayer and how to use the nasal sprayer correctly. Spray one full spray in each nostril, without tilting your head and without breathing through your nose while you spray. Wait 15 minutes, then spray once again in each nostril. Dispose of nasal sprayer and caps. You might experience relief from all migraine symptoms in as little as 30 minutes after taking Migranal. Migranal remains effective for 4 hours.

Side Effects

Serious cardiac events, including some that have been fatal, have occurred following use of DHE 45 but are extremely rare. During clinical studies and the foreign postmarketing experience with Migranal Nasal Spray, there have been no fatalities due to cardiac events. The most commonly reported adverse events in clinical trials for Migranal Nasal Spray were rhinitis, altered sense of taste, application site reactions, dizziness, nausea and vomiting. Adverse events associated with discontinuation were rhinitis, dizziness, facial edema, cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paresthesia. Postmarketing experience for DHE 45 has occasionally reported vasospasm, parathesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating, and pleural and retroperitoneal fibrosis after long-term use of dihydroergotamine.

Warnings

Migranal Nasal Spray and D.H.E.45 should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina. Migranal and D.H.E.45 also should not be given to patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications or methysergide within the last 24 hours, or patients with hemiplegic or basilar migraine. Migranal Nasal Spray and D.H.E.45 are also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function. Migranal Nasal Spray and D.H.E.45 should not be administered to pregnant women or nursing mothers.

Missed Dosge

No information available yet.

Drug Interactions

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.